Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation

Summary

Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to assess the safety and effectiveness of low molecular weight sulfated dextran (LMW-SD) on post-transplant islet function in people with type 1 diabetes who have responded to intensive insulin therapy.

Conditions

• Diabetes Mellitus, Type I

Interventions

DRUG

Low Molecular Weight Sulfated Dextran (LMW-SD)

Inhibitor of IBMIR

DRUG

Heparin

Anticoagulation

DRUG

CellCept® (Mycophenolate mofetil) OR Rapamune® (Sirolimus)

Cell proliferation inhibitor

DRUG

Prograf® (Tacrolimus) OR Cyclosporine

Calcineurin inhibitor

DRUG

Thymoglobulin® (Anti-thymocyte Globulin) - at first transplant

DRUG

Simulect® (Basiliximab) - at 2nd or 3rd transplant

Monoclonal IL-2 receptor blocker

DRUG

Klexane® (Enoxaparinsodium)

Anticoagulation Prophylaxis

DRUG

Trombyl® or Albyl-E® (Acetylsalicylicacid- ASA)

Anticoagulation Prophylaxis

DRUG

Enbrel® (Etanercept)

Anti-Inflammatory Therapy

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Clinical Islet Transplantation Consortium

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Olle Korsgren, MD · Uppsala University Hospital, Sweden

• Torbjörn Lundgren, MD · Karolinska University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-11

Primary Completion

2013-07-31

Completion

2014-08-21

Countries

• Norway
• Sweden

Study Locations